Panels › Clinical Toxicology › Product code NGL · Class 2
Test, Opiates, Over The Counter
Regulation 862.3650
1510(k)s in 12 months (23 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in NGL
| Company | 510(k)s | Recalls |
|---|---|---|
| Healgen Scientific,, LLC | 4 | 0 |
| Hangzhou Clongene Biotech Co., Ltd. | 3 | 0 |
| Amedica Biotech, Inc. | 2 | 0 |
| Guangzhou Decheng Biotechnology Co., Ltd. | 2 | 0 |
| Allsource Screening Solutions | 1 | 0 |
| Anhui Deepblue Medical Technological Co., Ltd. | 1 | 0 |
| Assure Tech., LLC | 1 | 0 |
| Eterbio, Inc. | 1 | 0 |
| Guangzhou Wondfo Biotech Co., Ltd. | 1 | 0 |
| Hangzhou AllTest Biotech Co., Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 23, 2025 | K253567 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card Healgen Scientific,, LLC | NGL |
| Apr 15, 2025 | K250803 | Deepblue Multi-Drug Urine Test Cup; Deepblue Home Muti-Drug Urine Test Cup Anhui Deepblue Medical Technological Co., Ltd., CN | NGL |
| Feb 20, 2025 | K250067 | Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro Guangzhou Decheng Biotechnology Co., Ltd., CN | NGL |
| Feb 6, 2025 | K242428 | Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fen Guangzhou Decheng Biotechnology Co., Ltd., CN | NGL |
| Dec 17, 2024 | K243365 | Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup Healgen Scientific,, LLC | NGL |
| Nov 20, 2024 | K243064 | ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold); ETERBIO Fentanyl/Norfentanyl Home Test Eterbio, Inc., CN | NGL |
| Nov 8, 2024 | K242802 | CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette Hangzhou Clongene Biotech Co., Ltd., CN | NGL |
| Oct 4, 2024 | K241869 | BioSieve Fentanyl FIA Home Test Kit; BioSieve Fentanyl FIA Pro Test Kit; BioSieve Toxismart Reader Vivachek Biotech (Hangzhou) Co., Ltd., CN | NGL |
| Aug 14, 2024 | K241969 | Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel; Hightop® Fentanyl/Norfentanyl Urine Rapid Test Panel Qingdao Hightop Biotech Co., Ltd., CN | NGL |
| Jul 16, 2024 | K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test Cassette; SAFElife T-Dip Fentanyl Ur Guangzhou Wondfo Biotech Co., Ltd., CN | NGL |
| May 22, 2024 | K241100 | Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard Co-Innovation Biotech Co., Ltd., CN | NGL |
| May 13, 2024 | K240949 | Healgen® Accurate Fentanyl Rapid Test Cassette (Urine); Healgen® Accurate Rapid Fentanyl Test Cassette (Urine); Healgen® Healgen Scientific,, LLC | NGL |
| Apr 12, 2024 | K240686 | Healgen Accurate Urine Drug Screen Dip Card; Healgen Accurate Home Urine Drug Test Dip Card Healgen Scientific,, LLC | NGL |
| Apr 10, 2024 | K240654 | SAFECARE Fentanyl Urine Test Cassette; SAFECARE FYL Urine Test Cassette Safecare Biotech (Hangzhou) Co., Ltd., CN | NGL |
| Mar 28, 2024 | K240295 | InstaStrip Fentanyl Rapid Test (Urine); InstaStrip Fentanyl Dipstick Test (Urine) Instanosis, Inc. | NGL |
| Mar 21, 2024 | K234006 | AllSource Drug Detector FenTest; AllSource Drug Detector Fentanyl Test Allsource Screening Solutions | NGL |
| Mar 6, 2024 | K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine) Assure Tech., LLC | NGL |
| Oct 26, 2023 | K233417 | AllTest Fentanyl Urine Test Cassette Hangzhou AllTest Biotech Co., Ltd., CN | NGL |
| Jan 31, 2020 | K193480 | BIOEASY Multi-Drug Test Cup Shenzhen Bioeasy Biotechnology Co., Ltd., CN | NGL |
| Mar 21, 2019 | K190412 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co., Ltd., CN | NGL |
| Jul 26, 2018 | K181790 | CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup Hangzhou Clongene Biotech Co., Ltd., CN | NGL |
| Apr 14, 2010 | K100108 | AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA Amedica Biotech, Inc. | NGL |
| Dec 19, 2008 | K082898 | AMEDICA DRUG SCREEN TEST CUP Amedica Biotech, Inc. | NGL |
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